Flash Glucose Monitoring Targets in Gestational Diabetes

Not Applicable

Recruiting

• Conditions: Gestational Diabetes Mellitus (GDM)

• Registration Number: NCT06774404
• Lead Sponsor: University Medical Centre Ljubljana

Brief Summary

The use of glucose monitoring sensors is already well-established in pregnant women with type 1 diabetes (T1D), where it has been proven to improve glycemic control and perinatal outcomes. However, it has not yet been sufficiently researched in the area of gestational diabetes (GDM). Some smaller studies have shown a favorable effect on glycemic control, but no statistically significant differences were observed in reducing perinatal complications. A randomized, prospective study will include 200 pregnant women with GDM, treated at the Diabetes Outpatient Clinic of the Clinical Department of Endocrinology, Diabetes, and Metabolic Diseases at the University Medical Centre Ljubljana. Participants will be divided into two groups. The first group will measure subcutaneous glucose using FSL in addition to self-monitoring of blood glucose (SMBG) while fasting and 60 minutes after main meals at the same time intervals. In both groups, glycemic targets, maternal outcomes, and neonatal outcomes will be monitored. In the FSL + SMBG group, sensor parameters for glycemic control will also be tracked.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-01
• Status Verified: 2024-10
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2025-01-08
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-05-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Pregnant women treated at the Diabetes Outpatient Clinic of the Clinical Department of Endocrinology, Diabetes, and Metabolic Diseases for gestational diabetes (GDM),
2. Agreement with the study protocol and ability to follow the study protocol,
3. Diagnosis of GDM established using the standard recommended OGTT method between the 24th and 28th weeks of pregnancy,
4. Age between 18 and 40 years.

Exclusion Criteria

1. History of bariatric surgery,
2. Treatment with systemic corticosteroids for more than 14 days prior to inclusion in the study,
3. Multiple pregnancy,
4. Hospitalization for psychiatric illness within the last year,
5. First visit to the Diabetes Outpatient Clinic after the 34th week of gestation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Glycemic control	Up to delivery	Average Fasting Glucose Concentration: Measured in mmol/L, calculated from fasting blood glucose readings and average Postprandial Glucose Concentration: Measured in mmol/L, based on glucose readings taken 60 minutes after main meals.

Secondary Outcome Measures

Name	Time	Method
Mean Glucose (MG) in FSL+ SMBG group	Up to delivery	Measured in millimoles per liter (mmol/L), reflecting the average glucose level recorded by the sensor.
Mean Amplitude of Glycemic Excursions (MAGE) (FSL+SMBG group)	Up to delivery	Measured in millimoles per liter (mmol/L), representing glycemic variability.
Time in Range - TIR (SMBG+FSL group)	Up to delivery	Defined as the percentage (%) of time sensor glucose levels fall between 3,5 and 7,8 mmol/l
Adherence to the Intervention	Up to delivery	Measured as the percentage (%) of completed prescribed self-monitoring and sensor glucose readings relative to the total number of prescribed measurements.
Gestational Weight Gain (GWG)	Up to delivery	Measured in kilograms (kg), calculated as the difference between pre-pregnancy weight and the last recorded weight before delivery.
Mode of Delivery	At delivery	Categorized into vaginal delivery, assisted vaginal delivery, or cesarean section, and reported as percentages (%) for each category.
Occurrence of Hypertensive Disorders	Up to delivery	Reported as a binary outcome (Yes/No), based on clinical diagnosis during pregnancy.
Small-for-Gestational-Age (SGA) Infant	At birth of infant	Defined as birth weight below the 10th percentile for gestational age, reported as a binary outcome (Yes/No).
Gestational Age at Birth	At birth of infant	Measured in completed weeks, based on the interval from the first day of the last menstrual period or ultrasound-confirmed dating.
Neonatal Hypoglycemia	At birth of infant	Defined as blood glucose levels below 2.6 mmol/L in the first 48 hours of life, reported as a binary outcome (Yes/No).
Pregnancy loss	<28 days of life	Miscarriage, stillbirth, neonatal death
Hyperbilirubinemia	Within first 7 days of life	Treated with phototherapy
Birth Weight	At birth of infant	Measured in grams (g), recorded immediately after delivery
Large-for-Gestational-Age (LGA) Infant	At birth of infant	Defined as birth weight above the 90th percentile for gestational age, reported as a binary outcome (Yes/No).

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia